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TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer (TMEM-MRI)

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ClinicalTrials.gov Identifier: NCT03694756
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jesus Anampa Mesias, Montefiore Medical Center

Brief Summary:
The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer (TMEM-MRI)

Condition or disease Intervention/treatment Phase
Breast Cancer Device: TMEM-MRI Procedure: FNA Not Applicable

Detailed Description:
The goal of this study is to assess the feasibility of a new imaging technology in the management of breast cancer. Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI) has the ability to detect tumor areas with more leakiness (perfusion), where cancer cell enter blood vessels to travel to other sites. This novel TMEM-MRI has potential to be used in clinical practice to identify tumors with high leakiness that might have higher chances to recur after breast cancer treatment. In addition, TMEM-MRI can potentially be used to assess response to preoperative treatments (chemotherapy, hormonal therapy) over time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be enrolled in 2 cohorts (A and B), based on breast biopsy status.
Masking: None (Open Label)
Masking Description: no need for masking, all patients will undergo TMEM-MRI
Primary Purpose: Other
Official Title: TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pre-biopsy patients
Patients identified by a radiologist at the time of diagnostic evaluation. Once consent is obtained, the TMEM-MRI will be scheduled. After TMEM-MRI, the patient will undergo core biopsy as per usual radiology procedure, with additional FNA at the time of core biopsy (preceding the core biopsy). MenaINV and MenaCalc will be calculated from the FNA material. After the breast biopsy confirms the suspected diagnosis of invasive breast carcinoma, the patient will be referred to breast surgery and a treatment plan devised, as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be also calculated from the specimen obtained at the time of definitive surgery. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.
Device: TMEM-MRI
TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.

Procedure: FNA
FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25 gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with EDTA.

Post-biopsy patients
Patients after breast biopsy. Once consent is obtained, patients will undergo TMEM-MRI. The patients will undergo definitive breast surgery and will receive adjuvant treatments as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be evaluated in final surgical specimen. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.
Device: TMEM-MRI
TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.




Primary Outcome Measures :
  1. Tumor permeability assessed by TMEM-MRI [ Time Frame: It will take you about 24 months to complete this research study outcome. ]
    Tumor permeability will be assessed by TMEM-MRI, and is defined as a number of Uth units (the number of tumor voxels with permeability density above threshold divided by the number of all tumor voxels) that will be obtained from the permeability map and TMEM-MRI algorithm.


Secondary Outcome Measures :
  1. TMEM density in breast cancer patients. [ Time Frame: It will take you about 24 months to complete this research study outcome. ]
    TMEM density is defined as the number of TMEM units visualized by triple immunohistochemistry in 10 high power fields (40X). TMEM density will be measured with a fully automated and scalable clinical assay for identification and enumeration of TMEM utilizing digital pathology methods coupled with image analysis

  2. MenaCalc [ Time Frame: It will take you about 24 months to complete this research study outcome. ]
    MenaCalc is calculated by subtracting the Z-score value of Mena11a from the Z-score value of pan-Mena, obtained by quantitative immunohistochemistry in formalin-fixed paraffin-embedded breast tumor specimens. MenaCalc can also be measured by qRT-PCR in cancer cells obtained by FNA

  3. MenaInv [ Time Frame: It will take you about 24 months to complete this research study outcome. ]
    MenaInv is calculated as pixel intensity obtained by quantitative immunofluorescence per area of formalin-fixed paraffin-embedded tumor tissue. MenaINV can also be measured by qRT-PCR in cancer cells obtained by FNA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • For pre-pilot phase (MRI sequence development):

    o Patients with a breast mass, with biopsy-proven histology of invasive breast carcinoma (any histologic type and ER,PR,HER2 status)

  • For pilot phase cohort A:

    o Patients with a breast mass considered highly suspicious for invasive carcinoma by the radiologist (BIRADS 5).

  • For pilot phase cohort B:

    • Patients with a breast mass found to be invasive ductal carcinoma on core biopsy.
    • The tumor should be considered operable by the breast surgeon.
    • No preoperative therapy for the current breast cancer is planned (endocrine therapy, chemotherapy, or radiation).
  • Tumor size/breast mass should be > 1 cm in largest diameter (radiologically).
  • Multifocal disease is allowed, as long as patients meet all eligibility criteria.
  • Age ≥ 18 years.
  • ECOG performance status 0-1.
  • Willingness to undergo a "research breast MRI".
  • Patient must be able to undergo MRI with gadolinium enhancement.

    • No history of untreatable claustrophobia.
    • No presence of non MRI compatible metallic objects or metallic objects that, in the opinion of a radiologist, would make MRI a contraindication.
    • No history of sickle cell disease.
    • No contraindication to intravenous contrast administration.
    • No known allergy-like reaction to gadolinium
    • No known or suspected renal impairment. GFR should be greater than 30 mL/min/1.73 m2.
  • Weight less than or equal to the MRI table limit.
  • Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria

  • Patients may not have had breast cancer or radiation therapy to the ipsilateral breast in the past.
  • No breast prosthetic implants (silicone or saline) are allowed.
  • Use of any investigational agent within 30 days of starting study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study.
  • Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694756


Contacts
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Contact: Jesus Anampa, MD,MS 7184058505 janampa@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Jesus D Anampa, MD,MS    718-405-8505    janampa@montefiore.org   
Contact: Karen Fehn, RN    7184058505    kfehn@montefiore.org   
Principal Investigator: Jesus Anampa, MD         
Sub-Investigator: Joseph Sparano, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Jesus Anampa, MD,MS Montefiore Medical Center

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Responsible Party: Jesus Anampa Mesias, Asst Prof. Dept of Medicine (Oncology), Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03694756     History of Changes
Other Study ID Numbers: 2018-9529
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jesus Anampa Mesias, Montefiore Medical Center:
TMEM;
Magnetic resonance imaging (MRI);
breast cancer.

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases